Peri-cardioversion and peri-ablation anticoagulation

Giuseppe Patti Campus Bio-Medico University of Rome What 2016 ESC guidelines recommend

Causes of TE events after cardioversion 1 Preexisting LA thrombosis 2 Atrial stunning causing thrombus formation 30-day incidence of TE events after cardioversion: - 4-6% without anticoagulation - <1% with anticoagulation

…. Irrespective of CHADS-VASC score CV and thromboembolic risk in 357 patients with AF duration <48 hrs

Patti G et al. Eur J 2016; Weigner MJ et al. Ann Int Med 1997 Left atrial thrombosis and dense spontaneous Echo contrast by TEE in patients with <48 hrs atrial fibrillation (N=366)

Kleeman T et al. J Am Soc 2009 Prevalence of intracardiac thrombi by TEE in 643 AF patients receiving different anticoagulation regimens and undergoing cardioversion (CHA2DS2-VASc score 4, INR ≥2, NOACs for 3 wks)

Zylla MM et al. Am J Cardiol 2015 Design: randomized, open-label, parallel- group, active-controlled multicentre study

Inclusion criteria: Age ≥18 years, non-valvular AF lasting >48 h or unknown duration, scheduled for cardioversion

Rivaroxaban Rivaroxaban 20 mg od* 20 mg od*

Early# R 1–5 days 42 days

2:1 VKA Cardioversion VKA Cardioversion OAC strategy 30-day Rivaroxaba Rivaroxaba follow-up n 20 mg n 20 mg od* od* ≥21 days

Delayed R (max. 42 days ofEndtreatment study 56 days) 2:1 VKA Cardioversion VKA NOACs vs warfarin in AF patients undergoing cardioversion Meta-analysis from 6CRTs (N=6,148)

Renda G et al. Am J Med 2016 Potential benefits of NOACs vs warfarin in the setting of cardioversion

 Rapid onset of action (2-4h), short half-life and predictable pharmacokinetics and pharmacodynamics allow a more rapid cardioversion strategy

 Low number of patients failing to achieve adequate anticoagulation pre-cardioversion (no delay)

 Safety

 Reduce costs Regional atrial contraction by color Doppler tissue imaging in controls

and 6-mo after cardioversion or RF ablation

Controls Cardioversion

Ablation

Boyd AC et al. Am J Cardiol 2009 General recommendations (ESC)

 All patients undergoing AF should be anticoagulated with a NOAC or a VKA (INR 2-3) for 3 weeks prior to the procedure and up to 8 wks

 TEE can be useful before the procedure to rule out LA thrombi

 In patients with and undergoing right-sided ablation, therapy with VKA or NOAC should not be interrupted and continued for ≥ 4 wks

 No need for anticoagulation for left atrial ablation of an accessory pathway or right atrial ablations (excluding atrial flutter) or right ventricular tachicardia ablation Interrupped vs uninterrupted warfarin in AF patients undergoing RF ablation

The randomized COMPARE study N=1,584)

Risk reduction in favour of uninterrupted

Di Biase L et al. Circulation 2014 Procedural recommendations (ESC):

 During the ablation, IV heparin should be administered to achieve an ACT of 300–350s

 It seems reasonable to use the same target ACT levels for heparin titration in NOAC-treated patients

 Especially with Dabigatran it has been noted that even in patients in whom the last NOAC dose was given in the morning of the procedure, the total need for heparin was higher and the time to target ACT lasted longer than in uninterrupted VKA patients. This likely reflects a difference in whole blood coagulability rather than a direct interaction between NOACs and the ACT test Efficacy and safety of NOACs vs warfarin in patients undergoing Radiofrequency catheter ablation of AF (25 studies; 9,881 pts)

Santarpia G et al. PLOS One 2015 Efficacy and safety of NOACs vs warfarin in patients undergoing Radiofrequency catheter ablation of AF (25 studies; 9,881 pts)

Santarpia G et al. PLOS One 2015  The majority of studies are single-center registries, case-controlled series or post-hoc analyses of prospective studies

 Available studies enrolled patients populations with different risk profiles

 No long-term follow-up are available

Cappato R et al. Eur Heart J 2015 Factors to consider for the timing of last NOAC intake:

- Kidney function

- CHA2DS2-VASc score

- Experience of the operator

- TEE in case of last NOAC intake ≥36 h before the intervention or doubtful adherence to correct NOAC intake in the weeks before ablation

Restart NOAC 4 hours after sheat removal, if complete haemostasis is achieved and there is no pericardial effusion 17 Prevention of early bleeding/entry-site complications

- Availability of imaging support to guide transseptal puncture

- Repeated ACT measurements during the procedure (even for ischemic events)

- Vein closure by suture compression after crio-ablation

- No data are available supporting higher safety of coagulation test-guided timing of the procedure NOACs vs warfarin in AF patients undergoing cardioversion

X-VERT study – Eur Heart J 2014 Classification of operations according to bleeding risk

Last NOAC intake before operation

Restart NOAC 4 hours after sheat removal, if complete haemostasis is achieved and there is no pericardial effusion. OAC is continued for 4-12 wks Efficacy and safety of NOACs vs warfarin in patients undergoing Radiofrequency catheter ablation of AF (25 studies; 9,881 pts)

Santarpia G et al. PLOS One 2015